Lorry Weaver Huffman

US Principal Consultant Regulatory Affairs

MT (ASCP), CLS (NCA)

Lorry is part of the US Regulatory Affairs team, her area of expertise is 510(k) submission and European Medical Device legislations. Her main activities are supporting manufacturers with getting FDA clearance and CE marking for all kind of devices.

Lorry has been in the medical industry for over 30 years working in large multi-national corporations, mid-sized companies, clinical laboratories, and the consulting business.  In this time, Lorry has developed Regulatory and Quality expertise spanning a broad range of product types. Product areas include Class II cardiovascular and renal devices, Class III cardiovascular implants, in vitro diagnostics ranging from standard microbe identification and antimicrobial susceptibility panels to genetic sequencing of bacteria, viruses, and tumor tissue as companion diagnostic (CDx) assays using next generation sequencing (NGS). Expertise includes developing US regulatory strategies, engaging with FDA through pre-submissions (Q-subs) to partner with FDA and the manufacturer in developing novel regulatory pathways, writing IDEs, 510(k)s, and PMAs.  

Lorry has international expertise having had global responsibilities in her past, namely Europe, Canada, Japan, and China. She earned her BS in Microbiology with a minor in Chemistry from Northern Arizona University and an MBA with Marketing emphasis from CSU-Sacramento. In addition, she is a licensed Medical Technologist and Clinical Laboratory Scientist with ASCP, NCA, and the State of California.

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